Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT02344992
Eligibility Criteria:
Inclusion Criteria:
* Type 1 Diabetes Mellitus ≥ 12 months
* Treated with multiple daily insulin injections or CSII ≥ 12 months
* BMI 18.5-28.0 kg/m² (both inclusive)
* HbA1C%≤9%
Exclusion Criteria:
* Type 2 Diabetes Mellitus
* Receipt of any trial product within 60 days prior to this trial
* Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
* Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
* Any systemic treatment with drugs known to interfere with glucose metabolism
* Use of any tobacco or nicotine-contained product within one year prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02344992
Study Brief:
Protocol Section:
NCT02344992